Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca's IMFINZI® (durvalumab) has received Priority Review from the FDA for treating muscle-invasive bladder cancer (MIBC). The decision is based on the NIAGARA Phase III trial results, which showed significant improvements in event-free and overall survival. The trial demonstrated a 32% reduction in disease progression risk and a 25% reduction in death risk with IMFINZI compared to standard treatment.

The treatment involves IMFINZI combined with neoadjuvant chemotherapy before radical cystectomy, followed by IMFINZI monotherapy. At two years, 67.8% of IMFINZI-treated patients were event-free compared to 59.8% in the control group, and 82.2% were alive versus 75.2% in the control group. If approved, this would be the first perioperative immunotherapy regimen in this setting.

Datopotamab deruxtecan demonstrated significant clinical activity in a pooled analysis of TROPION-Lung05 and TROPION-Lung01 trials for previously treated EGFR-mutated non-small cell lung cancer (NSCLC) patients. The analysis showed a 42.7% objective response rate in 117 patients, with a median duration of response of 7.0 months and disease control rate of 86.3%.

The drug showed similar efficacy in patients previously treated with osimertinib, achieving a 44.8% objective response rate in 96 patients. The safety profile remained consistent with previous reports, with stomatitis, alopecia, and nausea being the most common treatment-related adverse events.

AstraZeneca's IMFINZI has received FDA approval as the first and only immunotherapy for -stage small cell lung cancer (LS-SCLC) patients whose disease hasn't progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval is based on the ADRIATIC Phase III trial results, which demonstrated:

- 27% reduction in death risk versus placebo
- Median overall survival of 55.9 months vs 33.4 months for placebo
- 57% of IMFINZI-treated patients survived at three years vs 48% for placebo
- 24% reduction in disease progression or death risk
- Median progression-free survival of 16.6 months vs 9.2 months for placebo

The safety profile was manageable and consistent with known effects, with no new safety signals observed.

TRUQAP (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) has shown significant improvement in radiographic progression-free survival for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer in the CAPItello-281 Phase III trial. The study demonstrated an early trend towards overall survival improvement, though data were immature at analysis time. This marks TRUQAP as the first and only AKT inhibitor combination showing benefit in this specific prostate cancer subtype. The trial targets a critical patient population, as approximately 25% of the 200,000 annual mHSPC diagnoses have PTEN-deficient tumors, which typically indicate poor prognosis.

AstraZeneca has pledged $3.5 million to nonprofit organizations across the US through its Accelerate Change Together (ACT) on Health Equity initiative, bringing total contributions to over $15 million. The program will fund 53 nonprofit programs, including 45 local organizations receiving $30,000 each and eight national nonprofits sharing $2.15 million. The initiatives focus on improving healthcare access, addressing social determinants of health, advancing chronic disease care, and expanding STEM education in underserved communities. The funding supports programs targeting asthma, cardiovascular disease, COPD, heart failure, lupus, and oncology.

GRAIL announced the first patient testing in the global TROPION-Lung12 Phase 3 study using their Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay. The study, conducted under FDA approval, evaluates adjuvant treatments in Stage I adenocarcinoma NSCLC patients. The trial is sponsored by AstraZeneca in collaboration with Daiichi Sankyo.

GRAIL's blood-based methylation platform detects ctDNA without requiring tissue analysis, streamlining integration into clinical trials. Patients will be screened pre-surgery to determine eligibility for post-surgery treatment. This marks one of the first uses of ctDNA assay in early-stage lung cancer trials to identify patients who may benefit from additional treatment.

AstraZeneca reported strong financial results for 9M 2024, with Total Revenue up 19% to $39,182m and Core EPS increasing 11% to $6.12. Product Sales grew 19%, with significant growth across all therapeutic areas: Oncology (22%), CVRM (21%), R&I (24%), and Rare Disease (14%). The company maintained a Core Product Sales Gross Margin of 82% and Core Operating Margin of 32%. Based on strong performance and increased confidence in achieving sales milestones, AstraZeneca upgraded its FY 2024 guidance, now expecting high teens percentage growth for both Total Revenue and Core EPS.

AstraZeneca announces a $3.5 billion capital investment in the United States to expand its research and manufacturing footprint by 2026. The investment includes $2 billion of new funding that will create over 1,000 high-skilled jobs. The expansion encompasses a new R&D centre in Cambridge, Massachusetts, biologics manufacturing in Maryland, cell therapy facilities on both coasts, and specialty manufacturing in Texas. This investment is part of AstraZeneca's strategy to achieve $80 billion in Total Revenue by 2030. The US currently represents 44% of AstraZeneca's Total Revenue, making it the company's largest market with 17,800 employees across 17 sites in 12 states.

Daiichi Sankyo and AstraZeneca have submitted a new Biologics License Application (BLA) for accelerated approval of datopotamab deruxtecan to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior therapies. The application is based on the TROPION-Lung05 phase 2 trial, supported by additional trial data. The companies have withdrawn their previous BLA for nonsquamous NSCLC following FDA feedback. New results from a pooled analysis of patients with previously treated EGFR-mutated NSCLC will be presented at ESMO Asia 2024. The companies are conducting additional phase 3 trials evaluating the treatment alone and in combination with osimertinib.